Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-06-30

Brief Summary

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This study is to assess if shorter combinations of SSG plus single dose AmBisome®, Miltefosine plus single dose AmBisome® and Miltefosine alone are effective in treating visceral leishmaniasis in Eastern Africa.

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Detailed Description

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The current study intends to look at potential feasible short course combination therapies as well as evaluate (and possibly register) miltefosine in its conventional dose against VL in Sudan and Kenya.

Conditions

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Primary Visceral Leishmaniasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Amb+SSG

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11

Group Type EXPERIMENTAL

Liposomal amphotericin B (AmBisome®) and sodium stibogluconate

Intervention Type DRUG

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11

Amb+Milt

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11

Group Type EXPERIMENTAL

Liposomal amphotericin B + miltefosine

Intervention Type DRUG

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11

Milt

Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28

Group Type EXPERIMENTAL

Miltefosine

Intervention Type DRUG

Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28

Interventions

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Liposomal amphotericin B (AmBisome®) and sodium stibogluconate

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days of SSG at 20mg/kg body weight (IV/IM) from days 2-11

Intervention Type DRUG

Liposomal amphotericin B + miltefosine

AmBisome® one dose of 10mg/kg body weight (IV) on day 1 followed by 10 days Miltefosine at 2.5mg/kg body weight (oral) from days 2-11

Intervention Type DRUG

Miltefosine

Monotherapy course of Miltefosine at 2.5mg/kg body weight (oral) from days 1-28

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with clinical signs and symptoms of VL and diagnosis confirmed by visualization of parasites in tissue samples (lymph node, bone marrow or spleen where relevant) on microscopy.
* Patients aged between 7 (to allow for blood sampling) and 60 years (inclusive) who are able to comply with the protocol.
* Patients for whom written informed consent has been signed by the patients themselves (if aged 18 years and over) or by parents(s) or legal guardian for patients under 18 years of age.
* HIV negative status

Exclusion Criteria

* Patients who have received any anti-leishmanial drugs in the last 6 months/ relapse cases.
* Patients with a negative lymph node/bone marrow (or spleen) smears.
* Patients with severe protein and or caloric malnutrition (Kwashiorkor or marasmus ; Adults: BMI \</= 15, Children W/H\<70, presence of oedema)
* Patients with previous history of hypersensitivity reaction to SSG or Amphotericin B.
* Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patient's response to study medication.
* Patients suffering from other conditions associated with splenomegaly such as schistosomiasis.
* Patients with previous history of cardiac arrhythmia or an abnormal ECG
* Patients who are female of child bearing age (all females who have achieved menarche) / pregnant or lactating.
* Patients with haemoglobin \< 5gm/dl.
* Patients with WBC \< 1 x 10³/mm³.
* Patients with platelets \< 40,000/mm³.
* Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range.
* Patients with serum creatinine outside the normal range for age and gender.
* Major surgical intervention within 2 weeks prior to enrolment.

Minimum Eligible Age

7 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No